In situ implantation accessory for an autonomous intracardiac capsule

ABSTRACT

An implantation accessory for an intracardiac capsule includes a catheter with a catheter body and a tubular protection tip disposed at a distal end of the catheter body. The tubular protection tip includes a flexible portion disposed between a base portion structured to couple the tubular protection tip to the catheter body and a cylindrical portion structured to house the intracardiac capsule.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/295,688 filed Mar. 7, 2019, now U.S. Pat. No. 10,850,110, which is adivisional of U.S. application Ser. No. 15/071,015 filed Mar. 15, 2016,now U.S. Pat. No. 10,226,622, which claims the benefit of and priorityto French Patent Application No. 1552108, filed Mar. 16, 2015, all ofwhich are incorporated by reference herein, in their entireties.

FIELD

The present disclosure generally relates to “active implantable medicaldevices” as defined by Directive 90/385/EEC of 20 Jun. 1990 the Councilof the European Communities, including implantable devices thatcontinuously monitor heart rhythm and deliver to the heart, ifnecessary, electrical stimulation, resynchronization and/ordefibrillation pulses in the event of rhythm disorder detected by thedevice.

The present disclosure concerns the in situ implantation of such devicesthat have at their distal end a device anchoring member adapted topenetrate and anchor to tissue of a body wall at the chosen site ofimplantation.

BACKGROUND

A non-limiting example of such an anchoring member is a projectinghelical screw which axially extends from the body of the medical deviceand is intended to penetrate and screw into a cardiac tissue at theimplantation site. Other non-limiting examples of anchoring membersinclude needles, hooks, barbs, etc. that penetrate the tissue topermanently secure the medical device.

In a particular embodiment, the device is a capsule implanted in a heartchamber (ventricle, atrium or even arterial left cardiac cavity). Thecapsule may be autonomous, hereinafter referred to as an “autonomouscapsule” or “leadless capsule”. These autonomous capsules are devoid ofany physical connection to an implantable main device (such as thehousing of a stimulation pulse generator) or non-implantable device(external peripheral device such as a programmer or a monitoring devicefor remote monitoring of the patient), and for this reason, they arereferred to as “leadless capsules” to distinguish them from electrodesor sensors disposed at the distal end of a conventional lead, which istraversed throughout its length by one or more conductors galvanicallyconnecting the electrode or the sensor to a generator connected to anopposite, proximal end of the lead.

In another particular embodiment, a method is disclosed of delivering orinstalling, at a chosen implantation site, other types of medicaldevices, including, for example, stimulation leads in the form of atubular body having at its distal end an anchoring member for anchoringto a heart wall and an active portion provided withdetection/stimulation electrodes, and at its proximal end, mechanicaland electrical means for connection to a generator housing, where thegenerator housing is implanted remotely from the site of application ofthe pulses. The present disclosure can also be applied to other types ofimplantable devices, for example, in capsules intended for deliver insitu an active pharmacological agent.

In the case wherein the leadless capsules are endocardial capsules (thatis to say capsules to be fixed to the inner wall of a ventricular oratrial cavity, as opposed to epicardial capsules fixed to the externalwall of the heart), the implantation constraints are greater due to theapproach path, which involves going through the peripheral venous systemand then leading under fluoroscopy the capsule to the chosenimplantation site, both in an accurate and secure manner. It is onlyonce the site is reached and the capsule is firmly anchored in the heartwall that the operator can “release” the capsule, that is to say, canseparate it from the implantation accessory.

EP 2 818 201 A1 (Sorin CRM SAS) describes a system of in situimplantation of an intracardiac capsule with its accessory. Theautonomous capsule comprises a cylindrical tubular body provided at itsdistal end with an anchoring member adapted to penetrate a tissue wallof a cavity of the heart. The remotely steerable implantation accessorycomprises a catheter with an internal lumen, extended at its distal endby a protective tubular tip defining an interior volume adapted toreceive the capsule, the disconnectable means being provided forsupporting and guiding the capsule until the capsule is implanted at animplantation site. The implantation accessory further comprises asub-catheter movably housed within the lumen of remotely steerablecatheter. The sub-catheter and the capsule can be deployedtelescopically relative to the catheter between a retracted positionwherein the capsule and its anchoring means are completely housed insidethe tubular protective tip, and a deployed position wherein the capsuleis out to the tubular protective tip and is carried by the distal end ofthe sub-catheter. Finally, the distal end of the sub-catheter and theproximal region of the capsule are provided with securing means intranslation and in mutual rotation, these securing means beingdisconnectable to drop the capsule once in place.

The EP 2 818 201 A1 document also describes the constraints related tothis type of implantation, and the benefits of such a system. The EP 2818 201 A1 document can be referred to as needed and is herebyincorporated by reference in its entirety.

EP 2394 695 A1 (Sorin CRM SAS) describes a similar implantationaccessory but not implementing a telescopic sub-catheter. The capsule iscarried by the tip, and coupled thereto by a helical screw system. Theimplantation is made by bringing into contact the assembly formed by thetip with the capsule inside with the cardiac tissue and anchoring thecapsule to the tissue. After anchoring the capsule, a rotationalmovement imparted to the accessory simultaneously backs the tip anddecouples the capsule. As a precaution, a wire or thread connects thetip to the capsule in case it would be necessary to re-intervene toexplant the capsule, for example, if the originally chosen site wasunsatisfactory after an electrical test, and another site must be found.The wire or thread then guides the tip until it reaches the capsule onwhich it may then be coupled again to allow explanation of the capsule.The EP 2394 695 A1 document is hereby incorporated by reference in itsentirety.

Although this type of device is generally satisfactory, its endovenousand endocardial handling may present some risks because of its size, itsform factor, the effort required to transfer power, etc. These risks mayinclude: alteration of venous and/or cardiac tissue, alteration of thetricuspid valve or even cardiac perforation. Indeed, the thickness ofthe heart wall in close proximity to the classical target (the apex) isof the order of 1 to 2 mm only, and according to the methods ofimplantation, the doctor may need to directly touch this thin wall withthe protective tip itself, operated remotely (by femoral approach) via apowerful remotely steerable catheter, with the transmission of torqueand/or a significant axial push.

In addition, the use of such material is relatively undeveloped, aspractitioners are instead accustomed more flexible stimulation ordefibrillation leads.

OBJECT AND SUMMARY

The present disclosure proposes a system of the aforementioned type,wherein the stresses applied to the environment and pathway duringimplantation of such a capsule are significantly reduced, thus alsoreducing the risk of lesion or of injury during implantation, while alsoprotecting the device with its remotely steerable mechanism.

Another object of the invention is to achieve this without significantchanges for the practitioner.

Another object of the invention is to enable the practitioner tovisually observe the progression of the assembly, such as the tip andthe capsule it protects, so that the practitioner may initiatecorrective action if necessary.

The invention thus provides an in situ implantation accessory of anindependent intracardiac capsule comprising a cylindrical tubular bodyprovided at its distal end with an anchoring member adapted to penetrateand anchor to a tissue wall of a cavity of the heart.

This implantation accessory comprises: a remotely steerable catheterwith an internal lumen, extended at its distal end by a tip comprising abase to which the catheter is connected and a cylindrical portiondefining an interior volume adapted to receive the capsule; and asub-catheter housed within the lumen of the remotely steerable catheterwith a degree of freedom in relative translation and one degree offreedom in rotation relative to the remotely steerable catheter.

The sub-catheter and the capsule are telescopically deployable from thecatheter between i) a retracted position wherein the capsule and itsanchoring member are housed inside the tip, and ii) an extended ordeployed position wherein the capsule is output from the tip and iscarried by the distal end of the sub-catheter, and the distal end of thesub-catheter and the proximal region of the capsule are provided withfastening disconnectable means (e.g., a remotely detachable connector)in mutual translation and bending.

The tip has, between its base and its cylindrical portion, a flexibleportion forming an articulation (e.g., joint, hinge, flexible coupling)provides between the base and the cylindrical portion an elasticdeformability in bending and in compression.

According to various exemplary embodiments:

-   -   The flexible portion may have the shape of a sleeve of an        elastically deformable material, the sleeve traversed by a        series of orifices, and/or comprising a bellows-shaped region;    -   The flexible portion may have the shape of a cage, which may        comprise two spaced rings for fixation to the base and to the        cylindrical portion, and a plurality of elastically deformable        bars connecting the two rings to each other in a generally axial        direction;    -   The outer contour of the flexible portion may generally extend        in line with the contours of the cylindrical portion in the        axial direction of the tip;    -   The sub-catheter may have, in line with the flexible portion of        the tip, a deformation region adapted to facilitate the elastic        deformation of said flexible portion, while preserving the        necessary effort for the handling of the capsule during        rotations or translations, this deformation region may comprise        a tubular member formed by windings of a coil, at the ends of        which are the main part of the sub-portion of the sub-catheter        and the disconnectable securing means to which the capsule docks        (e.g., remotely detachable connector);    -   The protection tip may comprise, on either side of the flexible        portion, radiopaque markers;    -   The flexible portion may be at least partially radiopaque.

DRAWINGS

Further features, characteristics and advantages of the presentdisclosure will become apparent to a person of ordinary skill in the artfrom the following detailed description of preferred embodiments of thepresent disclosure, made with reference to the drawings annexed, inwhich like reference characters refer to like elements and in which:

FIG. 1 shows in perspective the general configuration of the variouselements of a capsule/catheter/protection tip according to the priorart.

FIG. 2 is a perspective view of a tip according to a first embodiment ofthe invention.

FIG. 3 is a perspective view and in half-section of the tip of FIG. 2 .

FIG. 4 is a perspective view and in half-section of the tip connected toa catheter which receives a capsule connected to a sub-catheter.

FIG. 5 is a perspective view of a tip (and of the associated end of thecatheter) according to a second embodiment of the invention.

FIG. 6 is a perspective view of an articulation element of the tip ofFIG. 5 .

FIG. 7 is a perspective view of a tip (and of the end of the associatedcatheter) according to a third embodiment of the invention.

FIG. 8 is a perspective view of an articulation element of the tip ofFIG. 7 .

DETAILED DESCRIPTION

We will now describe, for example, various embodiments of the presentdisclosure.

FIG. 1 , which illustrates the general architecture of the device, showsan implant accessory of a known type, bearing an autonomous leadlesscapsule referenced 10.

The leadless capsule 10 comprises a tubular body 12 provided at one ofits ends with a projecting helical anchoring screw 14 axially extendingthe tubular body and integral with the latter in rotation. The anchoringscrew 14 comprises in its distal portion a length of the order of 1.5 to2 mm of non-contiguous turns, adapted to penetrate the heart tissue soas to secure the leadless capsule 10 there. The anchoring screw 14 maybe an electrically active screw, that is to say playing, at least at itsdistal end, the role of a detection/stimulation electrode, or a passivescrew only used for anchoring the tubular body 12 in the wall of theheart chamber. In the latter case, the leadless capsule 10 may include aconductive axial needle 16 acting as a detection/stimulation electrodein contact with the myocardial tissue. Alternatively, it is alsopossible to provide a surface electrode.

The tubular body 12 includes various means and power supply circuits,for signal processing and for wireless communication to enable theexchange of signals with a remote, implantable or not, master device.

At its proximal end 18, the tubular body 12 of the leadless capsule 10comprises an axial securing rod 20 as described in detail in EP 2 818201 A1 cited above.

The leadless capsule 10 is intended to be introduced, via the vena cava,from a femoral puncture, as described in the same document.

A remotely steerable catheter 40 is provided at its distal end with atubular protection tip 50 having a base 52 to which the end of thecatheter 40 is fixed and a cylindrical portion 54 defining a centralhousing 56 for the leadless capsule 10 in a “retracted position”configuration as shown in FIG. 1 . The main function of the tubularprotection tip 50 is to protect the leadless capsule 10, and inparticular the anchoring screw 14, as it moves through the intravenouspathway, with its many curves, angulations, valves, etc. Conversely, thetubular protection tip 50 protects tissues from stripping riskspotentially caused by the translational movement of the anchoring screw14.

According to a particular illustrative embodiment, the outer diameter ofthe remotely steerable catheter 40 is between 10 and 15 French (6.6 to10 mm) for an inner lumen diameter of between 8 and 12 French (2.66 to 4mm). As for the tubular protection tip 50, it must be able toaccommodate the leadless capsule 10. Based on the dimensions of aleadless capsule currently manufactured by the Applicant, and accordingto another particular illustrative embodiment, the inner diameter of thetubular protection tip 50 is about 21 French (7 mm). Various otherdiameters could be used for the leadless capsule and the tubularprotection tip.

According to some embodiments, the catheter 40 may be a reinforcedstructure, such as a metal mesh or a coil embedded in the thickness ofthe catheter wall, so as to provide a capacity of torque transmissionapplied on the proximal maneuver handle to the distal end.

The implantation accessory may include a sub-catheter 30, introducedinto the central lumen of the remotely steerable catheter 40, and mobilein rotation and in translation relative to the latter. The sub-catheter30 may be used to ensure the deployment of the leadless capsule 10 outof the tubular protection tip 50 and to move the leadless capsule 10 tothe implantation site by a translational movement over a sufficientlength, typically 2 to 6 cm depending on the patient's anatomy.

The sub-catheter 30 may also be used to ensure the transmission oftorque from the proximal end (at the operating handle) to the distalend, and may serve as a reinforcement structure.

According to some embodiments the main part of the sub-catheter 30 maybe a conventional catheter-guide having a diameter of 4 to 6 French(1.33 to 2 mm), which is an existing, simple and economical device,responding to current torque transmission constraints, with lowcoefficient of friction inside and outside, with flexibility, etc., andwhich includes a proximal “Luer-Lock” connection enabling rapid assemblyof a multi-function adapter such as a rotational hemostasis valve or ofother compatible adapter with this sealed connection standard.Alternatively, the sub-catheter 30 may be used to inject a contrastmaterial to the back of the leadless capsule 10 so as to accuratelymonitor the operation under image intensification (e.g., fluoroscopy).

The coupling means of the sub-catheter 30 to the leadless capsule 10 atthe axial securing rod 20 is of the type described in EP 2 818 201 A1cited above and will not be described in more detail. Optionally, aretaining wire 32 forming a “breadcrumb” also described in the samedocument is provided.

Thanks to the coupling means, the release of the capsule may thus beperformed as explained in the aforementioned document, by a combinedmovement of screwing and traction in two steps:

-   -   Screwing of the capsule into the heart wall, by clockwise        rotation of the sub-catheter 30, under a slight push, and    -   Releasing the capsule, by a further clockwise rotation of the        sub-catheter 30, under slight tension in order to permit removal        of the sub-catheter.

According to an illustrative embodiment of the present disclosure, aproximal region of the protection tip 50 (proximal side) includes abendable elastic portion forming a hinge with low rigidity.

Referring to FIGS. 2 to 4 , according to an illustrative embodiment, aportion of the tubular protection tip 50 includes a sleeve 58 offlexible silicone extending between the base 52 and the rigid protectioncylinder 54, in which the sleeve 58 is generally aligned with saidprotection cylinder 54.

In some embodiments, the sleeve 58 may include one or more openings 58 afor decreasing its radial and/or axial stiffness. The shape andarrangement of the openings 58 a may vary to ensure the intendedfunction, which may include reducing the axial stiffness of the sleeveand limiting the front contact pressure when the system meets a wall.This particular embodiment also has the advantage of facilitating theflow of blood through the device and of avoiding the formation of clots.

In some embodiments, the base 52 and the protection cylinder 54 may alsohave holes 52 a and 54 a, respectively, to facilitate blood flow duringimplantation.

In some embodiments, the base 52 and the protection cylinder 54 may havelongitudinal radiopaque markers 59 not only to allow identification ofthe positioning of the imaging tip under X-rays, but also to see theplay or movement of the flexible joint 58 (e.g., the loss of alignmentbetween the catheter 40 and the tubular protection tip 50, or the mutualapproach of these two zones separated by the sleeve 58), therebyallowing the practitioner to relax or adjust the stress if necessary.

The axial ends of the sleeve 58 may be fixed to the rigid elementsrespectively forming the base 52 and the protection cylinder 54 forexample by gluing. As shown in FIGS. 3 and 4 , the fixation may beenhanced by an anchor formed by male portions 58 b of the sleeve 58 thatextend (either locally or over the entire extent of its edges) into thebase 52 and the protection cylinder 54 and engage counterpart cavities52 b and 54 b, of the base 52 and of the protection cylinder 54,respectively. The male portions 58 b and the counterpart cavities 52 band 54 b may use shape matching to reinforce the attachment of thesleeve 58 to the base 52 and the protection cylinder 54.

Other attachment means may of course be implemented.

Moreover, in some embodiments, the material forming the sleeve 58 may beloaded with radio-opaque particles so that the behavior of the sleeve 58may be observed during the procedure.

Alternatively, the sleeve 58 may be made of other flexible biocompatiblematerial such as flexible polyurethane.

It is also possible to provide the distal end region of the protectioncylinder 54 with a flexible sleeve 57 made of the same material as thesleeve 58 or of a different material (a technology called soft tip).

In some embodiments, the sub-catheter 30 has, at the level of the sleeve58, elastic deformation properties including at least one of bending,compression, and rotation. Without such properties, the relaxationprovided by the sleeve 58 might be diminished because of the rigidity ofthe sub-catheter 30. This feature on the catheter can be obtained, in apreferred embodiment and as illustrated by FIG. 4 , by providing thestructure of the sub-catheter 30, between a main portion 34 and asecuring portion 36 with the securing rod 20 for securing of the capsule10, a connection portion 38 formed by windings of a contiguous ornoncontiguous turn of a wire of a material (preferably a metal alloy)with carefully chosen elasticity properties.

As shown in FIG. 4 , the main portion 34 and the securing portion 36 ofthe sub-catheter 30 are inserted into the connection portion 38 and may,for example, be glued.

A description of embodiments of the elastically deformable sleeve 58, inaddition to those already discussed, will now be described.

Referring initially to FIGS. 5 and 6 , the sleeve 158, is in the form ofa cage with two circular rings 158 a, 158 b interconnected by axiallydirected peripheral bars 158 c. The rings may be made of a rigidmaterial, for example the same as that of the rigid elements 52, 54 ofthe tip, while the bars 158 c can be made for example from a microcablewith a diameter of the 0.2 to 0.5 mm made of a biocompatible metal alloywith carefully chosen elasticity properties, such as a nitinol alloy orMP35 NLT. Alternatively, with larger cross-section bars, one can chooseto make them into a flexible material such as soft silicone or softpolyurethane.

Such a sleeve has flexibility in bending, compression, and also inrotation.

Furthermore, the wide openings between the bars allow blood flow throughthe device and limit coagulation.

Another sleeve embodiment is illustrated in FIGS. 7 and 8 . The sleeve258, presents here the general shape of a bellows. More specifically,the sleeve comprises a main zone 258 c arranged in the form of a bellowsformed in one piece with the end portions in the form of radiallythicker rings, respectively 258 a, 258 b for respectively fastening thesleeve to the base 52 and to the protection cylinder 54 of the tip 50.

Other embodiments of the sleeve are of course possible. For example, itmay be formed of a spring with non-contiguous turns of metal alloy. Thespring may be covered with a thin layer of silicone to avoid jammingwith cardiac or valvular tissue.

It may be advantageous that the outer contours of the flexible portiongenerally extend in line with the contours of the cylindrical portion inthe axial direction of the tip, so as not to impede the progress of thetip housing the capsule as it moves along the access path.

The present disclosure offers numerous benefits, including thefollowing:

-   -   It improves system safety during implantation while requiring no        specific action by the practitioner;    -   Radiopaque elements or components on the base 52 and on the        cylindrical portion 54, and optionally on the sleeve 58, allow        fluoroscopic visualization during implantation as an additional        safety feature (visual warning to the practitioner);    -   The various configurations of the tip do not affect the        practitioner's maneuverability of the system through the pathway        (e.g. passage through the tricuspid valve);    -   The various embodiments do not compromise the smooth and gradual        exit of the capsule (no radial or longitudinal locking of the        capsule) or its attachment (local elastic deformability of the        tip is not likely to interfere with the tip of the screw 14 for        anchoring the capsule);    -   The system is sterile, has substantially the same footprint as        in the prior art, and does not generate significant additional        cost for its production;    -   Biocompatible materials are readily available to achieve the        elastically deformable articulation 58, 158, 258 of the tip.

What is claimed is:
 1. An implantation accessory for an intracardiaccapsule, the implantation accessory comprising: a catheter comprising: acatheter body; and a tubular protection tip disposed at a distal end ofthe catheter body, the tubular protection tip comprising: a flexibleportion disposed between a base portion structured to couple the tubularprotection tip to the catheter body and a cylindrical portion structuredto house the intracardiac capsule.
 2. The implantation accessory ofclaim 1, wherein the flexible portion is a sleeve of an elasticallydeformable material.
 3. The implantation accessory of claim 1, whereinthe flexible portion is traversed by a plurality of orifices.
 4. Theimplantation accessory of claim 1, wherein the flexible portioncomprises a bellows-shaped region.
 5. The implantation accessory ofclaim 4, wherein the bellows-shaped region comprises two end regionshaving radially thicker rings than a main portion of the bellow-shapedregion.
 6. The implantation accessory of claim 1, wherein the flexibleportion has the shape of a cage.
 7. The implantation accessory of claim6, wherein the cage comprises two spaced rings for fixing to the baseand to the cylindrical portion, and a plurality of elasticallydeformable bars connecting the two rings to each other in a generallyaxial direction.
 8. The implantation accessory of claim 1, wherein thetubular protection tip comprises radiopaque markers on either side ofthe flexible portion.
 9. The implantation accessory of claim 1, whereinthe flexible portion is at least partially radiopaque.
 10. Theimplantation accessory of claim 1, wherein the catheter is remotelysteerable.
 11. The implantation accessory of claim 10, wherein thecatheter body comprises an internal lumen configured to house asub-catheter.
 12. A tubular protection tip for a catheter configured tohouse an intracardiac capsule, the tubular protection tip comprising: aflexible portion disposed between a base portion for coupling thetubular protection tip to a catheter body of the catheter and acylindrical portion for housing the intracardiac capsule.
 13. Thetubular protection tip of claim 12, wherein the flexible portion is asleeve of an elastically deformable material.
 14. The tubular protectiontip of claim 12, wherein the flexible portion is traversed by aplurality of orifices.
 15. The tubular protection tip of claim 12,wherein the flexible portion comprises a bellows-shaped region.
 16. Thetubular protection tip of claim 12, wherein the flexible portion is acage.
 17. The tubular protection tip of claim 16, wherein the cagecomprises: two spaced rings for fixing to the base and to thecylindrical portion; and a plurality of elastically deformable barsconnecting the two rings to each other in a generally axial direction.18. The tubular protection tip of claim 12, wherein outer contours ofthe flexible portion extend generally in continuation of the contours ofthe cylindrical portion.
 19. The tubular protection tip of claim 12,wherein the tubular protection tip comprises radiopaque markers oneither side of the flexible portion.
 20. The tubular protection tip ofclaim 12, wherein the flexible portion is at least partially radiopaque.